title: Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments.
abstract: The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of biosimilar filgrastim in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. The background and methodology of this study are described in an article published concurrently in this journal. As important amendments have been made to the protocol, and the purpose of the prior article was to serve as a resource for future referencing, we detail these amendments in this present article: explicit statement about the use of biosimilar filgrastim for both primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia in the objectives and methodology of the study; length of observation; the addition of stage III and stage IV ovarian cancer and multiple myeloma to the tumor types studied; and the deletion of dose dense chemotherapy regimens as an exclusion criterion.
authors.affiliation: Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Gascón
authors.forename: Matti
authors.initials: M
authors.lastname: Aapro
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.forename: Nadia
authors.initials: N
authors.lastname: Rosencher
authors.forename: M
authors.initials: M
authors.lastname: Boccadoro
authors.forename: Matthew
authors.initials: M
authors.lastname: Turner
authors.forename: Karen
authors.initials: K
authors.lastname: MacDonald
authors.forename: Michael
authors.initials: M
authors.lastname: Muenzberg
authors.forename: Ivo
authors.initials: I
authors.lastname: Abraham
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D016568:Drugs, Generic; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy*; D011994:Recombinant Proteins
chemical_list: D016568:Drugs, Generic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim